Reporting to the Head of Clinical Scientists, Late Stage Metabolic Oncology, you will be acting as a clinical referent in the Study Team level, involved in the design, conduct follow-up, data interpretation and reporting of late phase clinical trials a late-stage commercial IDH inhibitor, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements. As part of an international team, you will contribute to the research and development in solid tumor and/or blood cancers within Servier’s Oncology portfolio.

Responsibilities :

• Partner with Clinical Lead on one or more clinical studies in a solid tumor and/or hematologic indication
• Assist in authoring key clinical study documents including Study Concept Sheet, Protocols, Clinical Study Reports, Annual Reports (e.g. IB, DSUR, PBRER), and informed consent forms
• Member of the clinical subteam and contributor to Clinical Development Plan, requiring a strong understanding of current disease landscape, competition, and potential for new indications  
• Serve as point of contact for clinical questions related to safety and efficacy data, including review of patient case summaries/patient profiles in order to assess clinical relevance, liaise with Global Safety, Data Management and Biostatistics for data review meetings as needed.
• Ensure appropriate training of staff on indication, product, and rationale of the study and clinical aspects (e.g. attend SIVs, refresher trainings, Investigator calls as needed). 
• Review of clinical data outputs, Interpret the clinical results of the study and propose complementary analyses
• Compilation and preparation of study results for internal/external communication (Abstracts, publications, posters)
• Build close relationships with study Investigators and KOLs
• Participation as clinical representative for internal or external audits and/or inspection by regulatory agencies

Description du profil :

• Advanced Clinical/Science degree preferred; MD, PharmD, MSc, etc. with strong experience in Clinical Development in Oncology; experience in hematologic malignancies a plus
• At ease with working in matrix organization (line management, functional management)
• Experience with global submissions preferred
• Ability to work autonomously and as part of a cross-functional international team
• Strong analytical skills and experience in data review and cleaning
• Good communication skills and ability to interact with all levels of personnel within the organization and with external clients and stakeholders (e.g. CROs, KOLs, etc.)
• Ability to partner efficiently with a senior clinical lead, and to act as team leader as delegated when appropriate
• Very good knowledge of English (in writing and speaking)
• Ability to anticipate and to innovate
• Demonstrated strong organizational skills, Problem solving skills, critical thinking and attention to detail
• Solid understanding of clinical development products and safety profile
• Minimum 3+ years of clinical research experience; pharmaceutical industry experience strongly preferred